The Recall Desk
HighFDA (Devices)·Z-0810-2016·Announced 2016-02-24

Philips recalls actuator assemblies for angiographic x-ray monitor ceiling suspension systems

Philips is recalling actuator assemblies for angiographic x-ray monitor ceiling suspension systems because the actuator can detach, causing the monitor carriage to drop.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (falling equipment) where injury has not yet been reported, which aligns with the 'High' severity criteria in the rubric.

Plain-English summary

Philips Electronics North America Corporation is recalling actuator assemblies for angiographic x-ray monitor ceiling suspension systems. The affected components include Actuator short Assy THC8AWDS-121 and Actuator long Assy THC8AWDS-122. These actuators are used with various Philips Allura Xper and INTEGRIS angiographic x-ray systems.

The recall is being issued because the actuator assembly can become detached, causing the monitor carriage with a flexvision monitor to drop to its lowest position. This presents a risk of injury to patients or medical staff in the vicinity of the equipment.

The recall involves 3,158 devices distributed worldwide, including the United States (nationwide, including Puerto Rico), Canada, and numerous other countries. Healthcare facilities should contact Philips to arrange for the replacement or repair of the affected actuator assemblies.

The recalled product

Product
Actuator for angiographic x-ray monitor ceiling suspension system. Actuator short Assy: THC8AWDS-121 and Actuator long Assy: THC8AWDS-122 used with the following products: 722001 Allura Xper FD 10 C; 722003 Allura Xper FD10; 722005 Allura Xper FD10/10; 722006 Allura Xper FD20;
Manufacturer
Philips Electronics North America Corporation
Category
Medical Device — Imaging Equipment
Hazard
Affected units
3,158

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Actuator short Assy: THC8AWDS-121 and Actuator long Assy: THC8AWDS-122

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Related recalls

Same manufacturer · Philips Electronics North America Corporation

See all →

Same hazard · falling object

See all →